This study will look to see if increasing the standard dose of Kaletra is tolerated and if it will lower viral loads to undetectable levels. This study will also look at the pharmacokinetic data (amount of Kaletra in blood at different times).

Further study details as provided by Community Research Initiative of New England:

Primary Outcome Measures:

To evaluate the pharmacokinetic parameters of higher doses of LPV/r

Secondary Outcome Measures:

To evaluate plasma HIV-1 RNA change after increasing the dose of LPV/r

To evaluate change in CD4 count after increased dose LPV/r

To compare the tolerability and laboratory safety profile of LPV/r 3 and 4 tablets BID

Study Start Date:

June 2006

Study Completion Date:

April 2007

Primary Completion Date:

April 2007 (Final data collection date for primary outcome measure)

Detailed Description:

There are several reasons for low level viremia in patients on Kaletra (LPV/r), including poor adherence, incomplete absorption, cellular drug pumps or resistance mutations. Increasing exposure to protease inhibitors via boosting with ritonavir increases minimum blood concentrations, and is a strategy which has been shown to improve suppression of virologic replication. Little is known about the pharmacokinetics (PK), tolerability and safety of increased doses of LPV/r. The objectives of this 24-week single arm pilot study are to assess the PK parameters, safety, tolerability, change in viral load and CD4 counts on increased dose (600/150 and 800/200 mg) LPV/r in participants with low level viremia on standard dose LPV/r-based ART. Participants will undergo six PK samplings over 12 hours on standard dose LPV/r. The dose will be increased to 3 tabs (600/150) BID and blood will be sampled for PK after two weeks. If tolerated at 8 weeks, the dose will be increased to 4 tabs (800/200 mg) BID and final PK sampling will be performed after two weeks. There will be a one time, optional, optimization of background regimen of NRTIs two weeks after the first dose escalation.

Prior treatment experience and resistance profile: Up to 20-fold resistance to LPV/r

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

CD4 Count >50

Viral load 200-75,000 on two most recent measures

More than 16 weeks on standard dose Kaletra (LPV/r)

May be initial PI regimen or prior PI usage

Up to 50-fold resistance to LPV/r

Exclusion Criteria:

Age < 18 years old

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414284